Our team has over 100 years of experience in the development of marketed biologics. Our experiences in biotechnology began as early as 1980 and several of us were key to early drug development at Genentech, demonstrated by over 30 years of cumulative time at this pioneering company. Team members have played major roles in the development of seven marketed products with a cumulative market value in excess of $20 billion. The protein products and drug candidates the team has worked with encompass a variety of classes of proteins such as: growth factors, cytokines, proteins in the clotting cascade, neurotrophic factors, fusion proteins and monoclonal antibodies.

Our Team

• Decades of experience in most phases of developing recombinant drugs

• Science trained team members with management depth and experience

• Hands on experience working on monoclonal antibodies, growth factors, receptor derivatives and proteins of the clotting cascade

• Directly involved in the development and support for the market entry of currently commercialized biotech drugs including: Herceptin, Avastin, Xolair, Activase, Raptiva and Kogenate

• Worked with multinational corporations and startup companies, alike

• Development support for biosimilars, particularly the following classes: oncology, clotting factors, inflammation and cystic fibrosis

Our Expertise

• Expression systems and cell line development

• Bioprocess development and manufacturing guidance; technology evaluation

• Process transfer – strategy and implementation

• Active experience in troubleshooting the development of several biosimilar products

• Process and manufacturing operations

• Production facilities layout, design and evaluation

• Recombinant drug project management, particularly in the CMC components

• Product development strategy – oncology, infectious diseases, metabolism, neurological disorders

• Intellectual property strategy, due diligence and expert witnessing

Our Resources

• Database of all currently approved recombinant biologicals including patent status, sales, production methods, expected yields

• Extensive network of contacts and allied experts